Kornimate/medical-research-clean huggingface dataset:
a study to evaluate efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab in patients with generalized myasthenia gravis

Conditions: Generalized Myasthenia Gravis

Summary: this study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gmg).


Eligibility criteria:
inclusion criteria: * signed informed consent form * for adolescent patients: informed consent form for study participation signed by the parents or a legal guardian, and patient assent obtained, as per local requirements * ability to comply with the study protocol procedures * confirmed diagnosis of gmg (anti-achr, anti-musk or anti-lrp4 present at screening) * a total mg-adl score of ≥ 5 points at screening with more than 50% of this score attributed to non-ocular items * mgfa severity class ii-iv * ongoing gmg treatment at a stable dose * for female patients of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab. exclusion criteria: * history of thymectomy within 12 months prior to screening * ocular mg (mgfa class i) and myasthenic crisis (mgfa class v) within the last 3 months prior to screening * known disease other than gmg that would interfere with the course and conduct of the study * positive screening tests for hepatitis b virus (hbv) and hepatitis c virus (hcv) * evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection) * receipt of live or live attenuated vaccine within 6 weeks prior to baseline * pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the last dose
rurality adapted physical activity sport health

Conditions: Brain Tumour; Metastatic Cancer

Summary: physical activity (pa) has been an integral part of non-drug therapy since the early 2010s. this supportive care is likely to reduce fatigue and improve the quality of life of patients during and after the cancer treatment phase. physical activity also has a protective effect in terms of tertiary prevention by reducing the risk of recurrence of certain cancers (breast, colon, prostate) by around 40 to 50% and by reducing overall mortality. adapted physical activity (apa) is offered at the institut de cancérologie de l'ouest (ico) in angers, but there are obstacles particularly linked to the geographical distance of the establishment where this activity is offered. the rapass project is a prospective study which will be proposed to patients followed at the ico, living in rural areas and far from angers. its main objective is to describe the fatigue and quality of life of patients before, during and after a 13-session home-based apa programme. the data collected will also be used to describe changes in physical condition and level, compliance with the programme, continuation of physical activity beyond the duration of the programme, and satisfaction.

the oncologist first assesses the patient's need for apa. the patient is then seen by the ico's apa coach (eapa) who presents the apa programme. if the patient agrees to participate, the coach assesses the patient's physical capacity in order to adapt the programme to their needs. the programme is then carried out with the departmental sports for all committee 49. the frequency of practice will ideally be one session per week at the patient's home, supervised by a coach from departmental committee for sport for all in 49. a total of 13 sessions will be carried out. the sessions will aim to develop all the components of physical fitness (endurance, strength, balance, flexibility, coordination, etc.). the patient receives a walking logbook to record the number of daily steps taken, an exercise booklet to work independently and a pedometer. in the presence of the coach, the patients perform different exercises and complete different questionnaires. the programme is evaluated by the ico eapa 3 months after the 13th and final session.

Eligibility criteria:
inclusion criteria: * performans status ≤ 2 * patient living in a rural area * patient with a brain tumour and/or metastatic cancer * patient with a medical prescription for apa practice * patient with a certificate of no contraindication to physical activity exclusion criteria: * persons deprived of their liberty, under court protection, under guardianship or under the authority of a guardian * patient unable to undergo the trial procedures for social or psychological reasons * patient who does not understand french

Keywords: adapted physical activity rurality oncology physical fitness supportive care
the importance of muscle function in patients with disseminated bladder cancer

Conditions: Urinary Bladder Neoplasm

Summary: this study investigates if reduced muscle mass and muscle function predispose to poor completion of oncological treatment in patients with bladder cancer (including cancer of the renal pelvis, ureter and urethra) and if muscle mass and muscle function change during oncological treatment in these patients. it also evaluates biomarkers for sarcopenia.


Eligibility criteria:
inclusion criteria: * informed consent * age ≥ 18 år * histologically verified cancer of the renal pelvis, ureter, bladder or urethra regardless of type of histology * ecog performance status 0 - 3 * meet the requirements for receiving oncological treatment (neoadjuvant chemotherapy for localized disease, chemotherapy or immunotherapy for disseminated disease). exclusion criteria: * age \< 18

Keywords: urinary bladder neoplasm urothelium neoplasm oncology muscle function sarcopenia
recruitment on extravascular lung water in acute respiratory distress syndrome (ards)

Conditions: Acute Respiratory Distress Syndrome; Acute Lung Injury

Summary: the purpose of this study is to investigate the change of extravascular lung water (evlw), cytokine and oxygenation parameters in patients with acute lung injury (ali) or acute respiratory distress syndrome (ards) after alveolar recruitment maneuver.

this investigation is a prospective randomized control study. informed consents will be obtained from all patients or their surrogates prior to the procedure of alveolar recruitment maneuver and picco monitoring system. patients and methods: from september 2010 to september 2012, consecutive patients with ali/ards undergo alveolar recruitment maneuver will be enrolled at chang gung memorial hospital, a university-affiliated hospital in taiwan. evlw will be measured by picco monitoring system, alveolar recruitment maneuver will be setting by protocol under supervision of chest physicians and respiratory therapists. serum cytokine such as endothelin-1, tnf-, il-6, tie-1, tie-2, angiopoietin-1, angiopoietin-2,vegf and thrombomodulin will be measured.

Eligibility criteria:
inclusion criteria: * acute hypoxemic respiratory failure requiring intubation; and hypoxemia, defined as a partial pressure of arterial oxygen (pao2) less than 100 mmhg under a high fraction of inspired oxygen (fio2) * pao2/fio2 ratio \< 200. exclusion criteria: * encephalopathy or coma, * a need for cardiac resuscitation, * hyperkalemia of more than 5.5 meq/l (contraindication to the succinylcholine use), * acute brain injury, * pregnancy, * age less 20 years old or recent thoracic surgery.
crossover comparison of tidal volume delivery during nasal intermittent positive pressure ventilation in preterm infants: infant cannula vs. nasal continuous positive airway pressure prongs

Conditions: Respiratory Distress Syndrome in Premature Infant

Summary: crossover bedside clinical study to examine relative tidal volume delivery during nasal intermittent positive pressure ventilation (nippv) and directly compare the ram® infant cannula to a nasal continuous positive airway pressure (ncpap) delivery system in vivo. the study population will consist of preterm neonates with mild respiratory insufficiency who are receiving nippv, non-invasive neurally adjusted ventilatory assist (niv nava), or ncpap.

bedside crossover study of neonates with mild respiratory distress receiving nippv. infants serve as their own controls and are randomized to initial interface of either ram® infant cannula or miniflow® ncpap prongs. infants are instrumented with the following monitoring equipment: edi orogastric tube to measure electrical activity of the diaphragm, transcutaneous monitor to measure transcutaneous co2 and o2, pulse oximeter to measure heart rate and oxygen saturation, and respiratory inductance plethysmography (rip) bands around the chest and abdomen to measure breathing movements and relative vt (arbitrary units, a.u.). data are continuously and simultaneously acquired using a data acquisition system. after 10 minutes of stabilization, infants receive 5 minutes of nippv on each of a sequence of four commonly used pressure settings (expressed as peak inspiratory pressure / positive end expiratory pressure): 16/5, 16/8, 20/5, 20/8. this sequence is not randomized and is constant between interfaces. subjects are then placed on the alternate interface, and the sequence is repeated. events ("breaths") are separated into 3 types: patient effort synchronized with nippv breaths (type i), nippv breaths without patient effort (type ii), and patient effort without nippv breaths (type iii).

Eligibility criteria:
inclusion criteria: * chronologic age less than 28 days * gestational age at birth between 24 weeks 0 days to 34 weeks 6 days * currently receiving nippv, niv nava, or ncpap exclusion criteria: * oxygen requirement greater than 40% * peak inspiratory pressure greater than 20 cm h2o * major congenital anomalies of the heart or lungs

Keywords: nasal intermittent positive pressure ventilation non-invasive ventilation nasal continuous positive airway pressure prongs infant nasal cannula tidal volume
study on the treatment of prurigo nodularis with stapokibart injection

Conditions: Prurigo Nodularis

Summary: this study is a multicenter, randomized, double-blind, placebo-controlled phase iii clinical study to evaluate the efficacy and safety of stapokibart injection in the treatment of subjects with prurigo nodularis, and observe pharmacokinetic characteristics, pharmacological effects, and immunogenicity.

chronic prurigo (cpg) is an independent chronic inflammatory skin disease characterized by chronic itching and multiple local or systemic prurigo lesions. prurigo nodularis (pn) is the main subtype of cpg.

Eligibility criteria:
inclusion criteria: * able to understand and agree to comply with the experimental process of this study and voluntarily sign the informed consent form. * 18 ≤ age ≤ 75 years old. * received at least 2 weeks of moderate or more potent topical corticosteroid therapy with insufficient efficacy. exclusion criteria: * with drug-induced prurigo nodularis. * with clinically significant diseases. * with severe liver and kidney function damage at the screening. * with malignant tumors within the first 5 years before the screening. * plan to undergo major surgical procedures during this study.
nurse-led mind-body intervention on sexual health for breast cancer survivors

Conditions: Women's Health: Neoplasm of Breast; Menopause, Premature; Body Image; Sexual Dysfunction; Cancer, Breast

Summary: the goal of this clinical trial is to test the efficacy of a nurse-led psychoeducational sexual health intervention for young women breast cancer survivors. the main questions it aims to answer are: 1. what is the feasibility of this intervention in an online, private setting? 2. what is the effect of this intervention on reducing menopausal symptoms, improving sexual functioning, and enhancing body image? participants will participate in a nurse-led psychoeducational intervention for 8 sessions lasting approximately an hour each over the course of 16 weeks. each participant will complete survey items at the beginning, end, and six-weeks after the last session. participants will be compensated up to $150 in gift cards as a thank-you for their time.


Eligibility criteria:
inclusion criteria: * diagnosed with breast cancer (stages i - iii) between ages 18 - 50 * completed active treatment (chemotherapy and/or radiation) within the last five years * can read/speak english * access to talk in quiet, safe environment for privacy * on hormonal therapies (aromatase inhibitors, tamoxifen) * currently partnered (i.e., in a relationship) exclusion criteria: * currently undergoing active treatment (chemotherapy and/or radiation) * more than five years have passed since completing active treatment (chemotherapy and/or radiation) * history of advanced breast cancer (stage iv) or a breast cancer recurrence * women without access to the internet * cannot read/speak in english

Keywords: breast cancer young women cancer survivorship sexual functioning body image premature menopause
hiv and ovarian reserve

Conditions: HIV; Infertility

Summary: recent evidence suggests a decline in fertility of persons living with hiv (plwh) (delayed pregnancies, sponteanous abortions, especially when patients receive an antiretroviral therapy, early menopause, amenorrhea and anovulatory cycles) with a possible decrease in ovarian reserve. however, indications of fertility preservation by freezing oocytes are nevertheless not clearly identified. the objective of this study is to evaluate the ovarian reserve before and after the implementation of antiretroviral treatment in plwh for whom the diagnosis of hiv has just been made.

this is a monocentric prospective cohort study with minimal risk and constraints. ovarian reserve is compared between two groups: 30 plwh, at time of diagnosis and 6, 12 and 18 months after initiation of an antiretroviral therapy, and 30 hiv negative women attending medically assisted procreation consultation for male infertility, age, bmi and smoking habits matched.

Eligibility criteria:
inclusion criteria: * for every participant : * woman aged 18 to 37 * covered by social security * able to give an informed consent case group only : * diagnosis of hiv infection during the 3 months before inclusion * concomitant initiation of an antiretroviral therapy with integrase inhibitors and nucleoside analogues control group only : * assisting medically assisted procreation consultation for male infertility * matching case subjects with age, bmi and smoking habits exclusion criteria: * for every participant : * current pregnancy * condition or associated treatment that may have an impact on fertility * premature ovarian failure * polycystic ovary syndrome * endometriosis control group only : - suspected hiv infection

Keywords: hiv ovarian reserve fertility preservation anti hiv agents
ivig versus placebo for the treatment of patients with severe c-diff

Conditions: Clostridium Difficile-associated Diarrhea (CDAD)

Summary: in this trial, eligible patients will be randomly assigned to receive a single dose of 400 mg/kg of ivig or a normal saline infusion as placebo over 4-6 hours, in addition to their usual medications for cdad. we expect to enroll approximately 40 patients over a period of two years from upmc shadyside hospital, mckeesport hospital, and st. margaret's hospital who are unresponsive to standard antimicrobial therapy for cdad. during the course of this study we expect that ivig group compared with placebo group will have fewer number of stools per day (\< 3 per day). secondary endpoints will include normal wbc count, normal body temperature, 75% reduction in abdominal pain / tenderness, and decrease in length of hospital stay. subjects will sign a written informed consent prior to any study procedures. patients will be monitored closely during the infusion of the study medication and will continue to be monitored on a daily basis up to the time of discharge. data collection will include vital signs, cbc, stool c. difficile cytotoxin assay, and stool counts before and after therapy.

see "brief summary" for details

Eligibility criteria:
inclusion criteria: 1. males and female greater than 18 years of age 2. positive stool c. difficile cytotoxin assay and/or biopsy evidence of pseudomembranous colitis (pmc) at onset of illness 3. current history of severe, relapsing cdad or current history of severe, refractory cdad 4. a score of 6 or 7 on the c.diff severity and prognosis score (cdsps) scale27,28,29,30 or failure to respond (as identified by a score of 4 or more on the cdsps scale below) to any of the following: a 4-day or more course of oral or iv metronidazole 500 mg po tid or qid; or to a 4-day course of oral vancomycin 125-500 mg po q6 hours; or to a 4-day course of vancomycin enemas; or failure to respond to a 4-day course of combination therapy of oral vancomycin 125-500 mg po q6 hours and iv metronidazole 500mg iv q8 or q6 hours and/or vancomycin enemas. cdsps scale (each item is scored as one point for a 7 point maximum total) 1. underlying immunosuppression/chronic medical condition 2. altered or depressed mental status as defined by medical chart documentation 3. abdominal pain and/or distention 4. wbc \> 20,000 or \ 10% 5. hypoalbuminemia (\<3 mg/dl) 6. ascites (clinically or per ct scan findings per medical chart) 7. abnormal ct scan findings per medical chart - exclusion criteria: 1. pregnant or lactating women 2. selective iga deficiency 3. hypersensitivity to immune globulin, human albumin, or thimerosal -
covid-19 follow up intensive care studies

Conditions: Quality of Life; COVID-19

Summary: since the sars-cov-2 infection is relatively new, the long term attributable burden related to covid19 has not been investigated yet. to date, in patients with covid-19 and their family members, there is little information on the functional status, cognitive ability, pattern of return to work, and health related quality of life after the icu admission. this study aims to describe the psychological wellbeing, physical - and social functioning of covid-19 icu survivors and their family members up to 12 months following icu discharge.

study design the covid-19 follow up intensive care study (cofics) is a single center, prospective cohort study performed at a university medical center in the netherlands. study population the study population consists of all admitted critically ill covid-19 patients with a \> 48 hours icu admission at the icu of a university medical center and a family member of the patient. family members in this study can be partners, other family members, or friends who are identified by the patient as important. sample size all consecutive patients admitted to the icu of the university hospital for respiratory distress due to covid-19 between march 19th 2020 and september 30th 2020 will be enrolled. with consent of the patient, family member(s) of participating patients will be enrolled.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * ability to speak and write dutch * ability to conduct a telephone call * diagnosed with covid-19 infection (only in patients) * 48 hours icu admission (only in patients) exclusion criteria: * refuse to participate * serious language barrier * cognitive impairment * severe psychiatric disorder * chronic ventilator dependency (only in patients)

Keywords: critical care family members patients follow-up studies quality of life covid-19
study of arginine metabolism and nitric oxide formation in relation to glutamine supply in severely burned patients

Conditions: Burns

Summary: the purpose of the study is to understand the way the body uses amino acids and proteins in burned patient during the time they cannot eat normally. this study aims to understand the metabolism of the amino acid arginine in the body after burn injury. the results of this study will help determine the best composition of food needed during an acute burn injury so that body can more efficiently use the supplied nutrient for optimal burn wound healing and early recovery.

the principle sources of plasma free arginine are (i) diet, (ii) release from protein breakdown and (iii) de novo synthesis directly from citrulline and the recycling of orthinine via the urea cycle. the major pathway of arginine disposal is i)oxidation via orthinine glutamate and subsequently the tricarboxylic acid (tca) cycle and ii)via formation of nitric oxide. the latter pathway plays an important regulatory role in the body's response to stress and is significantly increased after burn injury. previous studies with burn patients show i)an increased rate of total arginine flux, ii)a limited rate of arginine de novo synthesis, and iii) an apparent increase in the rate of arginine catabolism as measured indirectly by increased orinthine oxidation. these changes render arginine a conditionally essential amino acid for burn patients. studies have shown that feeding glutamine to healthy adults significantly alters the blood concentrations of urea cycle intermediates arginine, citrulline and orthinine. therefore, we hypothesize that the availability of arginine can be improved in the burn patient by supplementing total parenteral nutrition (tpn) support with glutamine. using stable isotope tracer studies our specific aims are: 1. to explore the dynamic aspects of arginine and citrulline metabolism. there will be an emphasis on arginine disposal via oxidation and urea nitrogen formation via nitric oxide production. 2. to explore the effect of a) depleting arginine and its immediate precursors proline and glutamine, and b)glutamine supplementation on the metabolic pathways of burn patients. 3. to estimate the rate of nitric oxide (no) formation in burn patients using arginine and citrulline tracers

Eligibility criteria:
inclusion criteria: * burn patients being treated at mgh burn unit with one or more of the following criteria: 1) \>=5% tbsa; 2) inhalation injury; or 3) resting energy expenditure (ree) of \>15% of the predicted basal metabolic rate using the harris-benedict equation. * must be receiving total parenteral nutrition in the course of their treatment. exclusion criteria: * patients with thyroid disease * patients who are not hemodynamically stable or show unstable vital signs * patients at the stage of major organ failure, e.g. renal and/or liver failure.

Keywords: parenteral nutrition burn injury stable isotopes arginine metabolic kinetics nitric oxide formation glutamine metabolic kinetics